Viewing data from:

OFLOXACIN

ANDA

OFLOXACIN | A076128 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

QUIMICA SINTETICA SAOFLOXACIN

DMF 147672000

CAMBREX CHARLES CITY INCOFLOXACIN USP

DMF 149282000

NEULAND LABORATORIES LTDOFLOXACIN USP

DMF 154332001

MAHIMA LIFE SCIENCES PRIVATE LTDOFLOXACIN USP

DMF 278872013

TURTLE PHARMA PRIVATE LTDOFLOXACIN USP

DMF 332502018

DAIICHI SANKYO PROPHARMA CO LTDInactiveOFLOXACIN BULK PRODUCT

DMF 63511986

NORAMCO INCInactiveOFLOXACIN

DMF 109221994

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveOFLOXACIN USP

DMF 142401999

CIPLA LTDInactiveOFLOXACIN USP

DMF 167532003

KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTDInactiveOFLOXACIN

DMF 173082004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 0.3%

0 patents0 exclusivities▴

SOLUTION/DROPS;OTIC | Approved: Mar 17, 2008

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Bausch and Lomb updated its corporate name from Bausch and Lomb Pharmaceuticals Inc to Bausch and Lomb Inc for the ofloxacin NDA 076128.

Old: BAUSCH AND LOMB PHARMACEUTICALS INC

New: BAUSCH AND LOMB INC

MODIFIEDApplicant7/1/2026

Bausch and Lomb's applicant name for ofloxacin (NDA 076128) was updated from "Bausch and Lomb" to "Bausch and Lomb Inc" in the FDA Orange Book.

Old: BAUSCH AND LOMB

New: BAUSCH AND LOMB INC